Late-stage development, FDA marketing authorization, procurement, and stockpile of antibiotics for the treatment of drug-resistant secondary bacterial infections and/or the treatment or PEP of…
Active Definitive Contract Awarded Last action
- Contract number
- 75A50126C00004
- Awardee
-
Shionogi Inc. UEI V8H8DT6RCHW6 Part of Shionogi & Company LIMITED
- Awarding agency
-
Office of the Assistant Secretary for Preparedness and Response
Department of Health and Human Services
- Obligated
- $156,103,541
Award facts
- Opportunity
-
- Pre Solicitation - Antibiotic for Treatment of Bacterial Pneumonia or Bloodstream Infections Pre-Solicitation · 75A50125R00005 · Posted Jun 27, 2025
- Contract value 32% obligated
-
- $156,103,541.00 Current, with exercised options
- $481,678,317.50 Potential, with all options
- Completion date 6% complete
- Current and potential, with all options
- NAICS code
- 541714 Research and Development in Biotechnology (except Nanobiotechnology)
- Set-aside
- No set-aside
- Competition
- Full and Open Competition · 1 offer Negotiated Proposal / Quote
- Pricing
- Cost Plus Fixed Fee
- Place of performance
- Florham Park, NJ 07932, USA
- Legislative mandates
-
- Service Contract Inventory FAR subpart 4.17
Award details come from SAM.gov/FPDS.
Transactions
| Action | Obligated | Date |
|---|---|---|
| Exercise an Option | $36,942,850 | |
| Original award | $119,160,691 |
About this award
The Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response awarded a definitive contract to Shionogi Inc. on April 6, 2026, for late-stage development, FDA marketing authorization, procurement, and stockpile of antibiotics for drug-resistant secondary bacterial infections and biothreat pathogen treatment or post-exposure prophylaxis, with a ceiling value of $481,678,317.50 under cost-plus-fixed-fee pricing.
Place of performance is Florham Park, NJ. The originating pre-solicitation, posted June 27, 2025, sought qualified vendors capable of advancing antibiotic development for hospital-acquired and ventilator-associated bacterial pneumonia, bloodstream infections, and biothreat pathogens. Vendors were required to demonstrate either programs with FDA end-of-Phase 2 meetings held or expected by May 1, 2025, with indications for HABP/VABP or BSI treatment, or approved antibiotics with sufficient data for biothreat indication development. Domestic manufacturing capability for drug substance and fill/finish operations was mandatory or required with a defined onshore transition plan. The contract covers personnel, materials, equipment, and facilities to support development, procurement, and stockpiling operations. Total period of performance spans no more than 120 months with overlapping base and option periods.
Description
Late-stage development, FDA marketing authorization, procurement, and stockpile of antibiotics for the treatment of drug-resistant secondary bacterial infections and/or the treatment or PEP of infections caused by biothreat pathogens.
Quick answers
Who was awarded contract 75A50126C00004?
75A50126C00004 was awarded to Shionogi Inc. by Office of the Assistant Secretary for Preparedness and Response (Department of Health and Human Services) on April 6, 2026.
How much is contract 75A50126C00004 worth?
The government has obligated $156,103,541 on 75A50126C00004. Its potential value, with all options, is $481,678,318.
Was contract 75A50126C00004 competed?
The extent of competition for 75A50126C00004 was full and open competition. The government received 1 offer.
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